Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 12:02 PM
Study NCT ID:
NCT01805232
Status:
UNKNOWN
Last Update Posted:
2013-03-06
First Post:
2013-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Artesunate and Malaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077332', 'term': 'Artesunate'}, {'id': 'D011803', 'term': 'Quinine'}], 'ancestors': [{'id': 'D037621', 'term': 'Artemisinins'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012717', 'term': 'Sesquiterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D002930', 'term': 'Cinchona Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2013-03-02', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clearance of the parasite and fever', 'timeFrame': '3 days', 'description': 'To compare the parasite clearance time and fever clearance time between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['severe', 'Falciaparum', 'Malaria'], 'conditions': ['Malaria']}, 'referencesModule': {'references': [{'pmid': '20850004', 'type': 'BACKGROUND', 'citation': 'Eltahir HG, Omer AA, Mohamed AA, Adam I. Comparison of artesunate and quinine in the treatment of Sudanese children with severe Plasmodium falciparum malaria. Trans R Soc Trop Med Hyg. 2010 Oct;104(10):684-6. doi: 10.1016/j.trstmh.2010.05.009. Epub 2010 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Intravenous artesunate is egual to quinine in the treatment of severe malaria', 'detailedDescription': 'Intravenous artesunate is egual to quinine in the treatment of severe malaria in the form of fever clearance time and parasite clearance time'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nsevere P.falciparum malaria-\n\nExclusion Criteria:\n\nmixed infection Pregnant women -'}, 'identificationModule': {'nctId': 'NCT01805232', 'acronym': 'IVAS', 'briefTitle': 'Intravenous Artesunate and Malaria', 'organization': {'class': 'OTHER', 'fullName': 'University of Khartoum'}, 'officialTitle': 'Intravenous Artesunate Versus Quinine in Severe Malaria at Kassla, Sudan', 'orgStudyIdInfo': {'id': 'artesunate and malaria'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'artesunate', 'description': 'intravenous artesunate 80 mg/kg initially then after 8 hours then daily', 'interventionNames': ['Drug: artesunate', 'Drug: Quinine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'quinine', 'description': 'quinine infusion 80 mg/kg every 8 hours', 'interventionNames': ['Drug: artesunate', 'Drug: Quinine']}], 'interventions': [{'name': 'artesunate', 'type': 'DRUG', 'description': 'intravenous artesunate 80 mg/kg initially then after 8 hours then daily', 'armGroupLabels': ['artesunate', 'quinine']}, {'name': 'Quinine', 'type': 'DRUG', 'description': 'quinine infusion 80 mg/kg every 8 hours till the patient can take orally', 'armGroupLabels': ['artesunate', 'quinine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '249', 'city': 'Kassala', 'state': 'Kassala', 'status': 'RECRUITING', 'country': 'Sudan', 'contacts': [{'name': 'Abzinab A Ali, MD', 'role': 'CONTACT', 'email': 'ishagadamm@yahoo.com', 'phone': '+249911259199', 'phoneExt': '122'}, {'name': 'Tajeldien A Abdulla, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kassala', 'geoPoint': {'lat': 15.45099, 'lon': 36.39998}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Khartoum', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Kassala, Sudan', 'class': 'OTHER'}, {'name': 'Kassala', 'class': 'UNKNOWN'}, {'name': 'Sudan', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ishag Adam', 'investigatorAffiliation': 'University of Khartoum'}}}}